Osteoarthritis of the HipPHRNCT06792539
Evaluate the Safety and Effectiveness of the Polymotion Hip Resurfacing (PHR) System Compared to Total Hip Arthroplasty
A study testing Polymotion Hip Resurfacing (PHR) System in people with Osteoarthritis of the Hip and Degenerative Joint Disease of Hip, run by JointMedica Inc. at 9 sites in 2 countries.
Trial summary
The goal of this clinical trial is to evaluate the safety and effectiveness of the Polymotion Hip Resurfacing (PHR) System compared to total hip arthroplasty, for adults who require hip resurfacing arthroplasty due to 1) non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Osteoarthritis of the Hip, Degenerative Joint Disease of Hip, Dysplasia; Hip
- What is being tested?
- Polymotion Hip Resurfacing (PHR) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 22 Jan 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
In order to be eligible to participate in this study, subjects must meet all of the following criteria:
- Requires primary hip resurfacing arthroplasty due to:
- non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, or
- mild dysplasia/developmental dislocation of the hip (DDH) up to Crowe Grade 1.
- Harris Hip Score < 70 points.
- Skeletally mature, age ≥21 and <65 years.
- Physically and mentally able and willing to comply with the Protocol, including the ability to read and complete required forms and willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol.
Subjects who meet any of the following criteria will be excluded from participating in this study:
- Inadequate bone stock or bone quality to support the device based on a Canal-Bone Ratio (CBR-7) of >0.45.0F
- Severe osteopenia, a medical history or increased risk of severe osteoporosis or severe osteopenia, a history of fragility fracture, and other conditions that lead to increased bone resorption
- Osteonecrosis or avascular necrosis (AVN)
- Multiple cysts of the femoral head (> 1cm) or cysts crossing the head-neck junction
- Metabolic disorders which may impair bone formation (e.g., osteomalacia, osteogenesis imperfecta, parathyroid disease, rickets, etc.)
- Severe femoral head deformities that will prevent fixation of the prosthetic resurfacing femoral head
- Inflammatory arthritis such as rheumatoid arthritis (RA)
- Severe proximal femoral rotational deformity in whom appropriate combined anteversion of femoral-acetabular construct is unachievable
- Severe acetabular dysplasia/development dislocation of the hip, defined as Crowe Grade ≥ 2
- Previous surgical intervention on index hip (e.g., treatment of hip fracture, arthroscopy)
- Severe medical comorbidities, including:
- severe cardiopulmonary disease,
- congestive heart failure,
- severe liver or kidney dysfunction,
- end-stage renal disease,
- severe uncontrolled diabetes,
- history of IV drug use,
- history of hypercoagulable state or pulmonary embolism,
- severe lumbar spinal stenosis,
- vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or post-operative recovery,
- neuropathic arthropathy (Charcot joint),
- immunosuppression or other immunodeficiency disorders, e.g., diseases such as Acquired Immune Deficiency Syndrome (AIDS) or post-organ transplant and on high doses of corticosteroids.
- Incompetent or deficient soft tissue surrounding the joint (e.g., hip abductor muscle deficiency)
- BMI > 40
- Active or suspected infection in or around the hip joint
- Known or suspected metal sensitivity (e.g., jewelry) or allergy to any implant materials
- Pregnant or plan to become pregnant during the study duration
- Current smoker
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Sinai Hospital / LifeBridge Health
Baltimore, Maryland, 21215
Rush University Medical Center
Chicago, Illinois, 60612
Midlands Orthopaedics & Neurosurgery
Columbia, South Carolina, 29210
Joint Implant Surgeons
New Albany, Ohio, 43054
NYU Longone
New York, New York, 10003
Hampton Road Orthopaedics
Newport News, Virginia, 23606
Oregon Health & Science University
Portland, Oregon, 97239
Florida Medical Clinic Orlando Health
Tampa, Florida, 33613
Bermuda1 site
Orthopaedic and Physiotherapy Associates
Paget, Trevelyan, DV04
About this study
Official title: A Multi-Center, Prospective, Non-Randomized, Pivotal Trial Evaluating the Safety and Effectiveness of the Polymotion Hip Resurfacing System
The goal of this clinical trial is to evaluate the safety and effectiveness of the Polymotion Hip Resurfacing (PHR) System compared to total hip arthroplasty, for adults who require hip resurfacing arthroplasty due to 1) non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, or 2) mild dysplasia/developmental dislocation of the hip (DDH) up to Crowe Grade 1.
Read the detailed description
The PHR® System is a single-use device consisting of a Cobalt Chromium, bone-cemented femoral head component, and a cementless acetabular component comprising of a Vitamin E polyethylene (Vit E-XPE) bearing with a titanium coating.
The PHR® System is intended for patients who, due to their relatively younger age (under 65) and increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring future ipsilateral hip joint revision.
Hip Resurfacing Arthroplasty (HRA) is a surgery that has been developed as an alternative to Total Hip Arthroplasty (THA), especially for younger, more active patients. Studies done on past designs of HRA demonstrate the following noteworthy benefits of the HRA procedure when compared with THA: bone conservation, improved gait, higher activity levels, lower rates of dislocations, reduced thigh pain, and reduced alteration in leg length. Hip resurfacing restores the natural shape of the joint meaning better stability, longevity, and higher levels of activity than a traditional hip replacement.
In Total Hip Replacement, the femoral head and neck (ball joint of the hip) is removed and replaced by a long, stemmed device. The procedure is highly successful; however, in some cases the replacement hip joint has the potential to wear out much more quickly in younger, more active patients, leading to revision surgery being required. With the PHR® procedure, your surgeon removes less bone from the femoral head of the femur and retains the femoral neck. The femoral head is shaped to accept a low-wear metal cap. This spherical cap closely matches your anatomy, reducing the risk of dislocation, and offering a broad range of movement and excellent stability. The acetabular socket (cup joint of the hip) is then fitted with a corresponding polyethylene component, significantly reducing potential reactions to metal ions associated with historic Metal-on-Metal hip resurfacing devices.
A comprehensive range of sizes is offered to address the needs of most patients. Both components are designed to be implanted, to achieve reconstructive and functional replacement of the hip joint. The PHR® System is intended to offer the traditional benefits of hip resurfacing over total hip arthroplasties, such as bone conservation and restoration of natural biomechanics, without a metal-on-metal articulating surface.
- Being tested
- Polymotion Hip Resurfacing (PHR) System
- Keywords
- hip resurfacing, Osteoarthritis of the Hip, deterioration of hip cartilage, Polymotion
- Medical subject headings
- Osteoarthritis, Hip, Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymotion Hip Resurfacing (PHR) SystemDevice
Surgical
| Study group | Role | What they receive |
|---|---|---|
| Polymotion Hip Resurfacing (PHR) System | Experimental | The investigational device, Polymotion Hip Resurfacing System ("Polymotion" or "PHR"), is a metal-onpolyethylene hip resurfacing device consisting of a metallic femoral component and an acetabular component made of Vitamin E HXLPE with a titanium coating on its bone-contacting surface.
Both components are designed to be permanently implanted, to achieve reconstructive and functional replacement of the hip joint. The PHR System is intended to offer the traditional benefits of hip resurfacing over total hip arthroplasty, such as bone conservation and restoration of natural biomechanics, without a metal-on-metal articulating surface. Receives: Device: Polymotion Hip Resurfacing (PHR) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to evaluate the safety and clinical effectiveness of the Polymotion Hip Resurfacing System.
The proportion of Polymotion subjects achieving Month-24 composite clinical success (CCS) will be compared to a propensity-score matched total hip arthroplasty control group collected from Rush University Medical Center, with the goal of demonstrating non-inferiority.
Composite clinical success will be analyzed via Harris Hip Scores measuring pain, activity, and function, absence of device subsidence, progressive radiolucencies, osteolysis or migration through radiographic assessment, and the absence of serious safety events (secondary surgical interventions for the index hip or serious device-related adverse events).
Measured: 24 months
Secondary outcomes (6)
Harris Hip Score, and sub-scores of HHS for pain and function
The Harris Hip Score is used to measure pain severity, function, and absence of deformity.
Each hip joint is scored on nine parameters, generating a total score representing the severity of the condition. The lower the score the better. The minimum score for each hip is 0 and the maximum is 53, giving a range for the total score of 0 to 106.
Measured: 24 months
SUSHI-University of California Los Angeles (UCLA) Activity Scores
The SUSHI-UCLA Activity Score is a 10-item assessment of physical activity level to assess patients overall state, pain and limitations of their hip.
Measured: 24 months
Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS JR), and sub-scores of HOOS JR for pain and function
The HOOS JR Survey is a short form of the HOOS that assesses patient pain (2 items), and functions of daily living (4 items).
Measured: 24 months
Forgotten Joint Score
The Forgotten Joint Score consists of 12 questions, scored on a 0-100 scale, intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment.
Measured: 24 months
SF-12
The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health.
Measured: 24 months
Radiographic success
Absence of migration, subsidence, and osteyloysis
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start22 Jan 2025
- Primary completionApr 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A multicenter, prospective, non-randomized, propensity score-adjusted, pivotal study
- Masking
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- JointMedica Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Mont, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792539
- Sponsor's protocol ID
- CI001
- Acronym
- PHR
- Status last verified
- Oct 2025
- First submitted
- 15 Jan 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Singh JA, Schleck C, Harmsen S, Lewallen D. Clinically important improvement thresholds for Harris Hip Score and its ability to predict revision risk after primary total hip arthroplasty. BMC Musculoskelet Disord. 2016 Jun 10;17:256. doi: 10.1186/s12891-016-1106-8.
PubMed 27286675Treacy RBC, Holland JP, Daniel J, Ziaee H, McMinn DJW. Preliminary report of clinical experience with metal-on-highly-crosslinked-polyethylene hip resurfacing. Bone Joint Res. 2019 Nov 2;8(10):443-450. doi: 10.1302/2046-3758.810.BJR-2019-0060.R1. eCollection 2019 Oct.
PubMed 31728182Cadossi M, Tedesco G, Sambri A, Mazzotti A, Giannini S. Hip Resurfacing Implants. Orthopedics. 2015 Aug;38(8):504-9. doi: 10.3928/01477447-20150804-07.
PubMed 26270748Joshi AB, Porter ML, Trail IA, Hunt LP, Murphy JC, Hardinge K. Long-term results of Charnley low-friction arthroplasty in young patients. J Bone Joint Surg Br. 1993 Jul;75(4):616-23. doi: 10.1302/0301-620X.75B4.8331119.
PubMed 8331119Dorr LD, Kane TJ 3rd, Conaty JP. Long-term results of cemented total hip arthroplasty in patients 45 years old or younger. A 16-year follow-up study. J Arthroplasty. 1994 Oct;9(5):453-6. doi: 10.1016/0883-5403(94)90090-6.
PubMed 7807101Bradley GW, Freeman MA, Revell PA. Resurfacing arthroplasty. Femoral head viability. Clin Orthop Relat Res. 1987 Jul;(220):137-41.
PubMed 3594982CHARNLEY J. Surgery of the hip-joint: present and future developments. Br Med J. 1960 Mar 19;1(5176):821-6. doi: 10.1136/bmj.1.5176.821. No abstract available.
PubMed 13809344Hu D, Tie K, Yang X, Tan Y, Alaidaros M, Chen L. Comparison of ceramic-on-ceramic to metal-on-polyethylene bearing surfaces in total hip arthroplasty: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 2015 Feb 3;10:22. doi: 10.1186/s13018-015-0163-2.
PubMed 25645809Varnum C. Outcomes of different bearings in total hip arthroplasty - implant survival, revision causes, and patient-reported outcome. Dan Med J. 2017 Mar;64(3):B5350.
PubMed 28260601Campbell P, Ebramzadeh E, Nelson S, Takamura K, De Smet K, Amstutz HC. Histological features of pseudotumor-like tissues from metal-on-metal hips. Clin Orthop Relat Res. 2010 Sep;468(9):2321-7. doi: 10.1007/s11999-010-1372-y.
PubMed 20458645Corradi M, Daniel J, Ziaee H, Alinovi R, Mutti A, McMinn DJ. Early markers of nephrotoxicity in patients with metal-on-metal hip arthroplasty. Clin Orthop Relat Res. 2011 Jun;469(6):1651-9. doi: 10.1007/s11999-010-1682-0.
PubMed 21108029Visuri T, Borg H, Pulkkinen P, Paavolainen P, Pukkala E. A retrospective comparative study of mortality and causes of death among patients with metal-on-metal and metal-on-polyethylene total hip prostheses in primary osteoarthritis after a long-term follow-up. BMC Musculoskelet Disord. 2010 Apr 23;11:78. doi: 10.1186/1471-2474-11-78.
PubMed 20416065Smith AJ, Dieppe P, Porter M, Blom AW; National Joint Registry of England and Wales. Risk of cancer in first seven years after metal-on-metal hip replacement compared with other bearings and general population: linkage study between the National Joint Registry of England and Wales and hospital episode statistics. BMJ. 2012 Apr 3;344:e2383. doi: 10.1136/bmj.e2383.
PubMed 22490979Kendal AR, Prieto-Alhambra D, Arden NK, Carr A, Judge A. Mortality rates at 10 years after metal-on-metal hip resurfacing compared with total hip replacement in England: retrospective cohort analysis of hospital episode statistics. BMJ. 2013 Nov 27;347:f6549. doi: 10.1136/bmj.f6549.
PubMed 24284336Gill HS, Grammatopoulos G, Adshead S, Tsialogiannis E, Tsiridis E. Molecular and immune toxicity of CoCr nanoparticles in MoM hip arthroplasty. Trends Mol Med. 2012 Mar;18(3):145-55. doi: 10.1016/j.molmed.2011.12.002. Epub 2012 Jan 12.
PubMed 22245020
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective, Non-Randomized, Pivotal Trial Evaluating the Safety and Effectiveness of the Polymotion Hip Resurfacing System
- ClinicalTrials.gov ID
- NCT06792539
- Acronym / sponsor ID
- PHR / CI001
- Keywords
- hip resurfacing, Osteoarthritis of the Hip, deterioration of hip cartilage, Polymotion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 238 participants (actual)
- Lead sponsor
- JointMedica Inc.University, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the safety and effectiveness of the Polymotion Hip Resurfacing (PHR) System compared to total hip arthroplasty, for adults who require hip resurfacing arthroplasty due to 1) non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, or 2) mild dysplasia/developmental dislocation of the hip (DDH) up to Crowe Grade 1.
Detailed description
The PHR® System is a single-use device consisting of a Cobalt Chromium, bone-cemented femoral head component, and a cementless acetabular component comprising of a Vitamin E polyethylene (Vit E-XPE) bearing with a titanium coating.
The PHR® System is intended for patients who, due to their relatively younger age (under 65) and increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring future ipsilateral hip joint revision.
Hip Resurfacing Arthroplasty (HRA) is a surgery that has been developed as an alternative to Total Hip Arthroplasty (THA), especially for younger, more active patients. Studies done on past designs of HRA demonstrate the following noteworthy benefits of the HRA procedure when compared with THA: bone conservation, improved gait, higher activity levels, lower rates of dislocations, reduced thigh pain, and reduced alteration in leg length. Hip resurfacing restores the natural shape of the joint meaning better stability, longevity, and higher levels of activity than a traditional hip replacement.
In Total Hip Replacement, the femoral head and neck (ball joint of the hip) is removed and replaced by a long, stemmed device. The procedure is highly successful; however, in some cases the replacement hip joint has the potential to wear out much more quickly in younger, more active patients, leading to revision surgery being required. With the PHR® procedure, your surgeon removes less bone from the femoral head of the femur and retains the femoral neck. The femoral head is shaped to accept a low-wear metal cap. This spherical cap closely matches your anatomy, reducing the risk of dislocation, and offering a broad range of movement and excellent stability. The acetabular socket (cup joint of the hip) is then fitted with a corresponding polyethylene component, significantly reducing potential reactions to metal ions associated with historic Metal-on-Metal hip resurfacing devices.
A comprehensive range of sizes is offered to address the needs of most patients. Both components are designed to be implanted, to achieve reconstructive and functional replacement of the hip joint. The PHR® System is intended to offer the traditional benefits of hip resurfacing over total hip arthroplasties, such as bone conservation and restoration of natural biomechanics, without a metal-on-metal articulating surface.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A multicenter, prospective, non-randomized, propensity score-adjusted, pivotal study
| Arm | Type | Receives |
|---|---|---|
| Polymotion Hip Resurfacing (PHR) System | Experimental | Device: Polymotion Hip Resurfacing (PHR) SystemThe investigational device, Polymotion Hip Resurfacing System ("Polymotion" or "PHR"), is a metal-onpolyethylene hip resurfacing device consisting of a metallic femoral component and an acetabular component made of Vitamin E HXLPE with a titanium coating on its bone-contacting surface. Both components are designed to be permanently implanted, to achieve reconstructive and functional replacement of the hip joint. The PHR System is intended to offer the traditional benefits of hip resurfacing over total hip arthroplasty, such as bone conservation and restoration of natural biomechanics, without a metal-on-metal articulating surface. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polymotion Hip Resurfacing (PHR) SystemSurgical | Device | Polymotion Hip Resurfacing (PHR) System |
Primary outcome
The primary objective of this study is to evaluate the safety and clinical effectiveness of the Polymotion Hip Resurfacing System.
Time frame: 24 months
The proportion of Polymotion subjects achieving Month-24 composite clinical success (CCS) will be compared to a propensity-score matched total hip arthroplasty control group collected from Rush University Medical Center, with the goal of demonstrating non-inferiority. Composite clinical success will be analyzed via Harris Hip Scores measuring pain, activity, and function, absence of device subsidence, progressive radiolucencies, osteolysis or migration through radiographic assessment, and the absence of serious safety events (secondary surgical interventions for the index hip or serious device-related adverse events).
6 secondary outcomes
Harris Hip Score, and sub-scores of HHS for pain and function
Time frame: 24 months
SUSHI-University of California Los Angeles (UCLA) Activity Scores
Time frame: 24 months
Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS JR), and sub-scores of HOOS JR for pain and function
Time frame: 24 months
Forgotten Joint Score
Time frame: 24 months
SF-12
Time frame: 24 months
Radiographic success
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 27286675Singh JA, Schleck C, Harmsen S, Lewallen D. Clinically important improvement thresholds for Harris Hip Score and its ability to predict revision risk after primary total hip arthroplasty. BMC Musculoskelet Disord. 2016 Jun 10;17:256. doi: 10.1186/s12891-016-1106-8.
- Background: PubMed 31728182Treacy RBC, Holland JP, Daniel J, Ziaee H, McMinn DJW. Preliminary report of clinical experience with metal-on-highly-crosslinked-polyethylene hip resurfacing. Bone Joint Res. 2019 Nov 2;8(10):443-450. doi: 10.1302/2046-3758.810.BJR-2019-0060.R1. eCollection 2019 Oct.
- Background: PubMed 26270748Cadossi M, Tedesco G, Sambri A, Mazzotti A, Giannini S. Hip Resurfacing Implants. Orthopedics. 2015 Aug;38(8):504-9. doi: 10.3928/01477447-20150804-07.
- Background: PubMed 8331119Joshi AB, Porter ML, Trail IA, Hunt LP, Murphy JC, Hardinge K. Long-term results of Charnley low-friction arthroplasty in young patients. J Bone Joint Surg Br. 1993 Jul;75(4):616-23. doi: 10.1302/0301-620X.75B4.8331119.
- Background: PubMed 7807101Dorr LD, Kane TJ 3rd, Conaty JP. Long-term results of cemented total hip arthroplasty in patients 45 years old or younger. A 16-year follow-up study. J Arthroplasty. 1994 Oct;9(5):453-6. doi: 10.1016/0883-5403(94)90090-6.
- Background: PubMed 3594982Bradley GW, Freeman MA, Revell PA. Resurfacing arthroplasty. Femoral head viability. Clin Orthop Relat Res. 1987 Jul;(220):137-41.
- Background: PubMed 13809344CHARNLEY J. Surgery of the hip-joint: present and future developments. Br Med J. 1960 Mar 19;1(5176):821-6. doi: 10.1136/bmj.1.5176.821. No abstract available.
- Background: PubMed 25645809Hu D, Tie K, Yang X, Tan Y, Alaidaros M, Chen L. Comparison of ceramic-on-ceramic to metal-on-polyethylene bearing surfaces in total hip arthroplasty: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 2015 Feb 3;10:22. doi: 10.1186/s13018-015-0163-2.
- Background: PubMed 28260601Varnum C. Outcomes of different bearings in total hip arthroplasty - implant survival, revision causes, and patient-reported outcome. Dan Med J. 2017 Mar;64(3):B5350.
- Background: PubMed 20458645Campbell P, Ebramzadeh E, Nelson S, Takamura K, De Smet K, Amstutz HC. Histological features of pseudotumor-like tissues from metal-on-metal hips. Clin Orthop Relat Res. 2010 Sep;468(9):2321-7. doi: 10.1007/s11999-010-1372-y.
- Background: PubMed 21108029Corradi M, Daniel J, Ziaee H, Alinovi R, Mutti A, McMinn DJ. Early markers of nephrotoxicity in patients with metal-on-metal hip arthroplasty. Clin Orthop Relat Res. 2011 Jun;469(6):1651-9. doi: 10.1007/s11999-010-1682-0.
- Background: PubMed 20416065Visuri T, Borg H, Pulkkinen P, Paavolainen P, Pukkala E. A retrospective comparative study of mortality and causes of death among patients with metal-on-metal and metal-on-polyethylene total hip prostheses in primary osteoarthritis after a long-term follow-up. BMC Musculoskelet Disord. 2010 Apr 23;11:78. doi: 10.1186/1471-2474-11-78.
- Osteoarthritis.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Mont, MD principal investigator
Principal Investigator
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polymotion Hip Resurfacing (PHR) System in people with Osteoarthritis of the Hip and Degenerative Joint Disease of Hip, run by JointMedica Inc. at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Bermuda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of this study is to evaluate the safety and clinical effectiveness of the Polymotion Hip Resurfacing System. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06792539, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.